Enforcing very effective nation-wide regulatory control of medical x-ray installations is known to be a daunting task in all countries. India is no exception. This is because x-ray units have been installed all over the country and are being use for several decades.

AERB’s effort to decentralize the regulatory control of medical x-ray equipment and installations is progressing steadily but slowly. AERB has signed MOU with Kerala, Mizoram, Madhya Pradesh, Tamil Nadu, Punjab, Chhattisgurh, Himachal Pradesh, Gujarat, Maharashtra and Odisha. DRS started functioning in Kerala and Mizoram.

Radiation Protection Rules 1971 did not directly deal with medical x-ray safety. Though the Central Government designated a competent authority to enforce the rules, during the early decades, the authority exercised only an advisory role in the case of medical x-ray use. But BARC developed the procedures to offer “Type approval” to the combination of x-ray tube, generator and couch and carried out R&D in related areas, and organized a few training programmes in the field.

Professor A.K.De the first Chairman of AERB initiated steps to strengthen the legal basis for the regulatory control of medical x-ray equipment and installations. For this AERB notified the surveillance procedures for the medical applications of radiation in 1989 and prescribed a safety code on medical x-ray equipment and installations. The Board appointed a technical committee chaired by Dr.Arcot Gajraj, eminent radiologist to review the safety status in the medical use of x-rays in the country.

AERB implemented most of the recommendations of the Gajraj Committee; its recommendation to set up AERB regional directorates did not find favour, though the need for decentralization was appreciated at different levels. Dr.I. S. Sundara Rao and Dr.Masood Ahmad played a significant role in developing legally defendable procedures to enforce regulatory control over medical x-ray equipment and installations.

AERB Research Project

During early nineties, AERB funded a research project to evaluate the status of radiation safety in the medical x-ray installations in Calicut district, Kerala. The Principal Investigator was Shri T.S.Sankaran Nair,then Medical Physicist and Radiological Safety Officer, the Department of Radiation Oncology, Calicut Medical College.

The survey highlighted several deficiencies such as lack of training, poor lay out of installations, lack of protective accessories etc

The results of this AERB funded project got some publicity in Kerala. The need for ensuring compliance with safety requirements prescribed by AERB became evident…

Public awareness

During mid nineties, several developments in Kerala led to greater sensitization of public on x-ray safety. A widely circulated newspaper in Kerala referred to an X-ray training institute hiring a beggar day after day to act as a patient! He got regularly exposed for a fee! This led to a spate of questions in the State Assembly.

Medical x-ray safety used to be a topic of discussion whenever any one from BARC visited the Regional Cancer Centre, Thiruvanathapuram… During one such visit, I discussed with RCC staff the possibility of starting an agency to carry out safety- surveillance of medical x-ray units in Kerala.

As a follow up of this discussion, Dr. T.P.Ramachandran, Medical Physicist and RSO at the RCC spoke to the then Health Secretary Shri Gopalkrishna Pillai. Shortly, Government of Kerala submitted a proposal to AERB for setting up a Directorate of Radiation Safety in the State.

On the same day, the Kerala Government issued an order constituting a committee to draw up a project document to set up the Directorate of Radiation Safety (DRS) in Kerala. The Committee members (Dr.T.P. Ramachandran & Shri T.S.Sankaran Nair both medical physicists cum Radiological safety Officers from RCC and Calicut Medical College and Dr. Pavithran, Associate Professor, Radiology department, Medical College Trissur, Shri P.K.Ghosh, Head, Industrial and Radiation Safety Division, AERB and Dr K.S.Parthasarathy, Secretary, AERB) met at Vikram Sarabhai Bhavan Bombay, on 10th and 11th March, 1994 and drafted the project document. Dr. G.Venkataraman Head, Radiation Protection Services Division, Bhabha Atomic Research Centre attended the meeting as an invitee. Dr. P.S.Iyer, Head, Radiological Physics Division, BARC, gave certain suggestions in writing. The Committee submitted the report on April 20, 1994.

The Government of Kerala approved the project document. AERB reviewed the document and suggested some changes. The Atomic Energy Commission approved the proposal to delegate certain powers to DRS. Kerala Government set up the Directorate of Radiation Safety. AERB authorized the Directorate of Radiation Safety to carry out certain functions prescribed by the Radiation Protection Rules 1971.

Constitution of the Directorate

Directorate of Radiation Safety is an independent agency directly under the Secretary (Health & Family Welfare). It enforces radiation safety provisions in the medical x-ray installations in Kerala. The Secretary, Department of H&F.W, Kerala State, has overall administrative control over those aspects of the working of the Directorate such as appointment of staff, providing infrastructure such as space, equipment and other amenities for the Directorate as per the prevailing rules of the State Government and the day-to-day operation of the Directorate. On technical matters, the activities of the Directorate will be conducted as per the guidelines of AERB. On behalf of AERB, I participated in the selection of essential staff including the Director and technical staff of DRS.

The State Government sanctioned a loan of Rs 25 lakhs to start the Directorate. The original proposal to generate funds to sustain the Directorate by levying some fees for various services could not be implemented because of legal reasons. Later, the State Government made provisions in its budget to support DRS.

Shri M. Shanmugha Das, Health Minister, Government of Kerala inaugurated DRS on January 3, 1999. Professor P.Rama Rao Chairman, AERB issued authorisation to DRS on March 4, 1999. The State Government appointed Shri T.S.Sankaran Nair as the first Director. I delivered the Dr T.P.Ramachandran Memorial Lecture at the Annual Conference of the Association of Medical Physicists of India (Kerala Chapter) at Kozhikode on the same day.

Dr.Ramachandran who played a crucial role in the formation of the Directorate was gentle, humble and soft-spoken; he was meticulous and hard working, a committed professional, a rare breed, endowed with great qualities of head and heart. The formation of DRS in Kerala was the one topic I used to discuss with him on every visit to the Regional Cancer Centre, till his untimely death.

AERB could provide addresses and safety related data of many medical x-ray installations in Kerala to DRS as an initial input. These data were a subset of those from the national survey of over 30,000 medical x-ray installations, organized by AERB with the support of CSIR and DRDO. Dr.Gopalakrishnan the then Chairman, AERB formulated the scheme in which ninety officials from these agencies carried out the survey after undergoing a brief training organised by BARC and AERB.

AERB sent a detailed communication on the programme to the authorities in 501 districts in the country through the NICNET service. It was indeed a unique programme, probably the like of which has never been attempted by any one else any where in the world. Shri P.K.Ghosh, then Head, Industrial and Radiation Safety Division, AERB and his colleagues collected the data ceaselessly and computerized them systematically. Because of this approach, AERB can provide initial inputs to the medical x-ray regulatory programme of any State setting up directorates similar to that of Kerala

Kerala Government instituted a truly innovative legal process to monitor the safety of x-ray installations. Exercising the powers conferred by the Section 79(j) of the Electric Supply Act 1948 and other enabling provisions, Kerala Electricity Board amended the regulation relating to the supply of electric energy to ensure that electric connection to x-ray units are provided only after getting clearance from DRS. The amended rules empowered the Board to disconnect power supply to x-ray plants “if and when, the Director of Radiation Safety, after due inspection and verification by authorized officials reports that, such equipment/plants used on human beings by the consumer and or his tenant or representative violated the Radiation Protection Rules 1971 and causes radiation hazard”.

DRS, Kerala is a shining example of the initiative taken by the Government of Kerala and is a model for other States to emulate. All advanced countries follow decentralization for effective regulatory control of medical x-ray equipment and installations. The Atomic Energy (Radiation Protection) Rules 2004 which replaced the Radiation Protection Rules 1971 envisages more exhaustive regulatory control of medical x-ray equipment and is in line with those in advanced countries.